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Study Comparing Fit of the iTotal Versus Standard Total Knee Implants

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ClinicalTrials.gov Identifier: NCT01861028
Recruitment Status : Terminated (Not enough patient volume to continue the study.)
First Posted : May 23, 2013
Results First Posted : December 28, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Tracking Information
First Submitted Date March 26, 2013
First Posted Date May 23, 2013
Results First Submitted Date July 16, 2019
Results First Posted Date December 28, 2020
Last Update Posted Date December 28, 2020
Study Start Date February 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 2, 2020)
  • Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater [ Time Frame: Intraoperatively, up to 120 minutes ]
    Fit will be measured in 4 quadrants on the tibia using a ruler to measure the distance between the customized implant and the edge of the tibia.
  • Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater [ Time Frame: Intraoperatively, up to 120 minutes ]
    Fit will be measured in 3 quadrants on the tibia using a ruler to measure the distance between the off-the-shelf design and the edge of the tibia.
Original Primary Outcome Measures
 (submitted: May 21, 2013)
Tibial and Femoral Implant Fit [ Time Frame: Intraoperatively ]
Fit will be measured in 5 quadrants on the tibia using a ruler to measure the distance between the implant and the edge of the tibia. Fit will be measured in the Medial-lateral dimension on both condyles on the femur in 5 or 6 different zones, depending on whether the femoral implant has 5 or 6 facets. Measurements will also be done in mm.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: May 21, 2013)
Knee Society Score [ Time Frame: 1 Year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
Official Title Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
Brief Summary This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants
Detailed Description

The study is designed as a single center, two arm analysis. The study will be completed in two phases, based on measurement type.

All additional data will be obtained from pre and post-operative subject surveys, operative and discharge records and radiographs.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients receiving either a standard total knee implant or an iTotal patient-specific total knee implant
Condition Osteoarthritis
Intervention Not Provided
Study Groups/Cohorts
  • Phase I
    A series of 50 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements
  • Phase II
    The Phase I (50 consecutive primary iTotal patients) will also have implant fit data assessed for the femur. After final implantation is complete measurement will be assessed and recorded. A series of 25 primary knees that are scheduled for Standard TKR implants will then undergo the same measurements of the femur.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: December 2, 2020)
44
Original Estimated Enrollment
 (submitted: May 21, 2013)
75
Actual Study Completion Date December 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients who are scheduled for a standard total knee replacement
  • Patient who are scheduled for patient-specific total knee replacement (iTotal)
  • Patient age > 18 years

Exclusion Criteria:

  • Patients who do not receive a total knee replacement
  • Unwilling or unable to comply with study requirements
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01861028
Other Study ID Numbers 12-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party ConforMIS, Inc.
Study Sponsor ConforMIS, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Gregory Martin, MD JFK Medical Center
PRS Account ConforMIS, Inc.
Verification Date July 2019